UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035840 |
|---|---|
| Receipt number | R000040710 |
| Scientific Title | Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2019/08/15 02:56:50 |
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Basic information
Public title
Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Acronym
Advance Care Planning conducted by non-physician providers in Japanese primary care clinics
Scientific Title
Advance Care Planning conducted by non-physician providers in Japanese primary care clinics : Mixed Method Research
Scientific Title:Acronym
Advance Care Planning conducted by non-physician providers in Japanese primary care clinics
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Medicine in general | Geriatrics | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objectives of this evaluation is to establish an understanding of a practical way of ACP by non-physician providers in Japanese primary care clinics, including (1) Feasibility of ACP conducted by non-physician providers; and (2) Effective timing to conduct ACP systematically in busy workflow.
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We will assess feasibility of ACP conducted by non-physician providers in Japanese primary care clinics by data from semi-structured interview and questionnaire.
Key secondary outcomes
We will assess effective timing to conduct ACP systematically in busy workflow by data from semi-structured interview and questionnaire.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
We will train non-physician providers to be ACP facilitators. They will facilitate ACP for patients who are willing to discuss future medical care.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will include patients who are willing to discuss future medical care, such as patients at the time of getting an opinion letter for LTC insurance, at the time of discharge and at the time of transition to regularly home visit use.
Key exclusion criteria
We will exclude patients who cannot express their thoughts.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Mochizuki |
Organization
Japan Association for Development of Community Medicine (JADECOM)
Division name
Institute of Community Medicine
Zip code
1020093
Address
2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL
03-5212-9152
t-mochizuki@jadecom.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Horie |
Organization
Japan Association for Development of Community Medicine
Division name
Institute of Community Medicine
Zip code
1020093
Address
2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
TEL
03-5212-9152
Homepage URL
hhorie@jadecom.jp
Sponsor or person
Institute
Japan Association for Development of Community Medicine (JADECOM)
Institute
Department
Personal name
Funding Source
Organization
Japan Association for Development of Community Medicine (JADECOM)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oregon Health & Science University Department of Family Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
JADECOM IRB
Address
2-6-3 Hirakawacho Todoufukenkaikan15F, Chiyoda-ku, Tokyo, Japan
Tel
03-5212-9152
hhorie@jadecom.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東通村診療所(青森県)、久瀬診療所(岐阜県)、西浅井地区診療所(滋賀県)、都祁診療所(奈良県)、
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040710
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
